MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER HEEL INT 5 PACK; DRESSING,WOUND,OCCLUSIVE

Catalog Number	66800506
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that allevyn gentle border heel 23 cm x 23.2 cm 5 pack recently one of the healthcare professionals at (b)(6) had asked for samples for alternative to the allevyn life heel.The healthcare professional then had a fellow coworker "where" the heel just to test out before using it on a patient.Although the heel dressing did fit better and was much more comfortable it did leave behind gel beads as well as a sticky silicon on the coworkers foot.
Additional Manufacturer Narrative
The device intended to be used in treatment has not been returned for evaluation, but photos and additional information provided we have been able to establish a relationship between the device and the reported event.The photos supplied confirm silicone remained on the carrier as described.The root cause is determined as a raw material issue.No batch/lot number has been provided, therefore a review of the device history has not been possible the complaint history file contains no further instances.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: ALLEVYN GENTLE BORDER HEEL INT 5 PACK
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10593608
• Report Number: 8043484-2020-02985
• Device Sequence Number: 11060854
• Product Code: NAD
• UDI-Device Identifier: 05000223465247
• UDI-Public: 5000223465247
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 66800506
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1